EFFECT OF Salvia Hispanica l. (CHIA) IN THE BIOCHEMICAL METABOLIC SYNDROME COMPONENTS

June 25, 2015 updated by: Ana Elena Perez Verdin, Instituto Mexicano del Seguro Social

EFFECT OF Salvia Hispanica L. ( CHIA ) IN THE BIOCHEMICAL METABOLIC SYNDROME COMPONENTS IN PATIENTS IN THE NATIONAL MEDICAL CENTER WEST OF THE MEXICAN SOCIAL SECURITY INSTITUTE

The objective of this study is to evaluate the effect of the administration of 25 g of chia per day, for 90 days on the biochemical components of the metabolic syndrome in subjects with this condition

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The metabolic syndrome (MS) is a cardiovascular risk factor and is present in about 20-25% of the world's adult population. Individuals with this condition have twice the risk of cardiovascular disease and die from it, compared with those who do not and 5 times more likely to develop type 2 diabetes mellitus (DM2). For this reason, it is appropriate to develop better tools for prevention and management of MS, with more emphasis on lifestyle´s changes. Chia has been studied in the past 10 years due to its high concentration of omega-3 alpha-linolenic acid (ALA) and 6 linoleic acid (LA) showing beneficial effects in some components of MS in rodents and individuals. The addition of chia to the conventional treatment of MS for the modification of metabolic disorders provides us a tool for easy incorporation into daily life, inexpensive and accessible in our environment.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44340
        • Recruiting
        • Instituto Mexicano Del Seguro Social Hospital de Especialidades, Centro Medico Nacional de Occidente Lic. Ignacio Garcia Tellez Unidad Medica de Alta Especialidad
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of metabolic syndrome according to Adult Treatment Panel - III criteria.
  • Subject wishing to participate in the study by written consent.
  • Instituto Mexicano del Seguro Social beneficiaries subject
  • Subject who not requiring modification of medical treatment for MS in the recruitment period.

Exclusion Criteria:

  • Chronic renal failure with filtration glomerular rate clearance less than 30ml / min.
  • Diabetic neuropathy.
  • Post menopause
  • Intestinal malabsorption diseases .
  • Type 2 diabetes with HbA1c > 8.5 %
  • Systolic and diastolic blood pressure >140/90 mmHg.
  • Triglycerides > 300 mg/dL.
  • LDL cholesterol >160mg/dL.
  • Systemic autoimmune diseases .
  • Cirrhosis or liver failure .
  • Subject infected with human immunodeficiency virus or acquired immunodeficiency syndrome .
  • Diagnosis of cancer with active disease.
  • Subject previously undergoing bariatric surgery.
  • Pregnancy or lactation.
  • Alcoholism and drug addiction.
  • Subject who consume high fiber dietary supplements and / or omega 3 acids.
  • Subject taking anorexic drugs.
  • Subject under diet for weight loss implemented by a health professional.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Free diet plus Chia
This subjects will consume 1 cookie oatmeal with chia before breakfast and dinner for 90 days without changing their diet
Dietary supplement: Chia
The subject will eat 25 gr of chia in 2 oatmeal cookies at day
Other Names:
  • Salvia hispanica
Experimental: Normocaloric diet plus chia
This subjects will consume 1 cookie oatmeal with chia before breakfast and dinner for 90 days along with a normocaloric diet
Dietary supplement: Chia
The subject will eat 25 gr of chia in 2 oatmeal cookies at day
Other Names:
  • Salvia hispanica
Behavioral: Normocaloric diet
The healthy diet plan distribution will be 50% carbohydrate, 25 % protein, 35 % fat to less than 7 % saturated fat and less than 200 mg/d cholesterol and 20-30 g of fiber.
Active Comparator: Normocaloric diet plus oatmeal
This subjects will consume 1 cookie oatmeal before breakfast and dinner for 90 days along with a normocaloric diet
Behavioral: Normocaloric diet
The healthy diet plan distribution will be 50% carbohydrate, 25 % protein, 35 % fat to less than 7 % saturated fat and less than 200 mg/d cholesterol and 20-30 g of fiber.
Dietary supplement: Oatmeal
The subject will eat 2 oatmeal cookies a day containing the exactly same quantity of oats in the oatmeal cookies with chia.
Other Names:
  • Oats
Active Comparator: Normocaloric diet
This subjects will only go under a normocaloric diet for 90 days
Behavioral: Normocaloric diet
The healthy diet plan distribution will be 50% carbohydrate, 25 % protein, 35 % fat to less than 7 % saturated fat and less than 200 mg/d cholesterol and 20-30 g of fiber.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum glucose levels
Time Frame: 94 days (plus or minus 4 days)
Fasting, postprandial and post challenge oral test glucose and HbA1c
94 days (plus or minus 4 days)
Variation in lipid profile
Time Frame: 94 days (plus or minus 4 days)
Triglycerides, HDL-cholesterol, LDL-cholesterol and total cholesterol
94 days (plus or minus 4 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modification in insulin resistance
Time Frame: 94 days (plus or minus 4 days)
Serum insulin, homeostasis model assessment index
94 days (plus or minus 4 days)
Change in systolic blood pressure
Time Frame: 94 days (plus or minus 4 days)
94 days (plus or minus 4 days)
Change in diastolic blood pressure
Time Frame: 94 days (plus or minus 4 days)
94 days (plus or minus 4 days)
Variation in body weight
Time Frame: 94 days (plus or minus 4 days)
94 days (plus or minus 4 days)
Modification in waist circumference
Time Frame: 94 days (plus or minus 4 days)
94 days (plus or minus 4 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Mexicano del Seguro Social

Investigators

  • Principal Investigator: Ana E Perez Verdin, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

May 1, 2016

Study Registration Dates

First Submitted

June 22, 2015

First Submitted That Met QC Criteria

June 22, 2015

First Posted (Estimate)

June 24, 2015

Study Record Updates

Last Update Posted (Estimate)

June 26, 2015

Last Update Submitted That Met QC Criteria

June 25, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-2015-785-047

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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